In Vitro Diagnostic Regulation Definition
Medical device regulation (MDR) 2017/745 is the latest set of regulations that govern the clinical investigation, production, and distribution of medical devices in Europe. This regulation applies to medical devices that come into direct contact with humans (e.g., bandages, catheters, implants). Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. MDR 2017/745 went into effect on May 26, 2021 and replaces the EU’s previous Medical Device Directive (MDD) and Active Implantable Medical Devices Directive.
Under this new regulation, some medical devices will have stricter oversight by notified bodies, and manufacturers will need to provide more in-depth clinical data to demonstrate their safety and performance claims. In addition, the classification for some medical devices (i.e., Class I, IIa, IIb, or III) will change. Devices that meet the requirements of the regulation will receive a CE Mark.